Flocare Transition Giving Sets

Official notice

27 Jan 2016

Last checked

27 Jan 2016

High riskACCC

An official ACCC notice concerns Flocare Transition Giving Sets. If a transition adaptor is used and it leaks or breaks, it could lead to patients receiving less feed than intended. For some patients, especially critical and/or volume sensitive patients, this can have a negative impact on their health if it not noticed for a significant period of time. Leakage can occur immediately after connection or over time. Published 2016-01-27.

What to do now

If you or someone you care for uses Flocare transition giving sets for tube feeding, you can continue to use them. These products are not being removed from the market. Please note that this issue only affects you if you use MLL and mobile giving sets that have a white transition adaptor on the patient-end which connects to a luer feeding tube. It does not apply to situations in which the transition adaptor is unscrewed and discarded during connection. However, if this issue does affect you, you are advised to carefully check transition adaptors for any minor defects, avoid over-tightening connectors, and monitor for leakage after initial connection and again about two hours after connection. If any problems are identified or suspected, replace the transition giving set with a new one. If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can contact Nutricia Australia on 1800 060 051.

Recall number

7f945c1c-804e-42ca-9032-3f07795c99b6

Official notice

2016-01-27

The hazard

If a transition adaptor is used and it leaks or breaks, it could lead to patients receiving less feed than intended. For some patients, especially critical and/or volume sensitive patients, this can have a negative impact on their health if it not noticed for a significant period of time. Leakage can occur immediately after connection or over time.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

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Models

DESCRIPTION CODES

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Affected products

Product 1

Flocare Infinity Pack Giving Set MLL W/O DC – Transition Flocare Infinity Bottle Giving Set – Transition Flocare Infinity Pack Giving Set W/O DC & W/O MP - Transition Flocare Infinity Bottle Giving Set W/O MP – Transition Flocare Infinity Pack Mobile Giving Set – Transition Flocare Infinity Pack Mobile Giving Set W/O MP - Transition

Risk / hazard

If a transition adaptor is used and it leaks or breaks, it could lead to patients receiving less feed than intended. For some patients, especially critical and/or volume sensitive patients, this can have a negative impact on their health if it not noticed for a significant period of time. Leakage can occur immediately after connection or over time.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

7f945c1c-804e-42ca-9032-3f07795c99b6

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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